Exhibit 10.1
DISTRIBUTION AGREEMENT
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This DISTRIBUTION AGREEMENT ("Agreement"), effective as of March 31, 2011
('"Effective Date"), is entered into by and between Competitive Technologies,
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Inc. ("CTTC"). a Delaware corporation having a place of business at:
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Competitive Technologies, Inc.
0000 Xxxxx Xxxxxxx Xxxx, Xxxxx 000
Xxxxxxxxx, XX 00000, X.X.X.
And Life Episteme Italia S.r.l. ("Distributor"), an Italian Company with its
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legal headquarters at:
Xxx Xxx Xxxxxxx X.00, 00000 Xxxx, Xxxxxx
WITNESSETH
WHEREAS, CTTC owns (Schedule 1 "CTTC exclusive rights to Market") the exclusive
rights to worldwide Marketing, Distribution and Sales of the Calmare(R) Pain
Therapy medical device (Model MC-5A and any subsequent improvements and models)
exclusively based upon the Scrambler Therapy scientific principle, whose Patent
is owned by Delta Research & Development and, more specifically. Xxxxxxxxx
Xxxxxxxx Xxxxxxx. For simplicity of purpose in this Distribution Agreement it
shall be referred to as "Calmare(R)/Scrambler", whatever other names might be
referenced in other public documents.
WHEREAS, Calmare(R)/Scrambler is also sometimes referred in various public
documents, and in particular, as "Apparatus and Method for Quick Pain
Suppression", "Transcutaneous Electrical Nerve Stimulator for Pain Relief, "Pain
Stopper", "Electrical Neuropathic Treatment", "MC-5A" pain device or unit, and
all those names are referring to "Calmare(R)/Scrambler" (Schedule 2
"Calmare(R)/Scrambler and other associated names"). Specifically, all other
names shall be incorporated by reference into "Calmare(R)/Scrambler" as used
herein.
WHEREAS, Patent registration for Calmare(R)/Scrambler has been filed (Schedule 3
"Calmare(R)/Scrambler Patent filing") in the Country/Countries assigned in the
Territory of interest to Distributor.
WHEREAS, CTTC has provided Distributor with all the following
Calmare(R)/Scrambler documentation: (Schedule 4 "Calmare(R)/Scrambler CE Xxxx")
(Schedule 5 "Calmare(R)/Scrambler FDA clearance") (Schedule 6
"Calmare(R)/Scrambler Declaration of Country of Origin") (Schedule 7
"Calmare(R)/Scrambler Declaration of Conformity") (Schedule 8
"Calmare(R)/Scrambler Warranty Coverage") (Schedule 9 "Calmare(R)/Scrambler
Technical Assistance") so that Distributor, based on its knowledge of applicable
local laws and business practice, has fully and carefully evaluated the market
and its legal framework in Distributor's Territory and decided that the Products
are adequate and suitable for lawful and financially and economically feasible
distribution within Distributor's Territory.
WHEREAS, specifically, Calmare(R)/Scrambler can be marketed, presented, loaned,
rented, leased, sold for end-patient use performed ONLY by Hospitals, Clinics,
or other professional Medical Practices/Doctors and, in particular, NEVER
marketed, presented, loaned, leased sold to private individuals.
WHEREAS, more particularly, Calmare(R)/Scrambler can be loaned, rented, leased,
or sold only after completing specified instruction and training, performed by
qualified and authorized
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professionals (Schedule 10 "Calmare(R)/Scrambler Authorized Training") to
professionals following the Calmare(R) User's Manual, and Calmare(R) Tutorial
and Study Guide.
WHEREAS, CTTC wishes to appoint Distributor as the exclusive sales channel for
certain identified product(s), and Distributor desires to provide such services
to CTTC, in each case, on the promises, terms and conditions set forth herein.
NOW THEREFORE, in consideration of the mutual promises and covenants set forth
herein, the Parties agree as follows:
1.0 RIGHT TO DISTRIBUTE
1.1 CTTC hereby grants Distributor the exclusive rights to purchase from
CTTC, and the exclusive right to distribute the Products identified (Schedule 11
"Product (s) Patent filing") solely within the Territory as defined hereinafter.
1.2 CTTC hereby grants Distributor the exclusive right to sell solely in the
Territory as defined hereinafter (Schedule 12 "Country/Countries in assigned
Territory"). Any opportunity to sell outside assigned Territory must be
authorized in advance in writing through CTTC Management, and any such request
by Distributor shall be evaluated on a case-by-case basis to determine potential
conflict with any other ongoing Business Activities, before providing
authorization from CTTC to Distributor to proceed according to negotiated terms
and conditions in any newly assigned Territory not presently included in
Schedule 12. Specifically, Distributor is not authorized to conduct any
marketing and/or distribution of Calmare(R) in another Distributors' Territory.
1.3 CTTC hereby grants Distributor a "Right of First Refusal Option" to
accept or to refuse the opportunity to engage in the sales of other CTTC
Products when available in the future. The Distributor has a period of sixty
(60) days to execute an "Option" exercise after receiving official notification
from CTTC of the availability of Other Products; failure to do so within the
specified period shall be automatically considered as an implicit and express
refusal to exercise this right of first refusal option.
1.4 Distributor shall purchase the Product(s) for resale from CTTC at the
price set forth in the present Agreement (Schedule 13 "Pricing"). That Schedule
may be amended by CTTC three (3) years after the date of this Agreement.
1.5 All orders for current identified Product(s) shall be sent by
Distributor ONLY to CTTC, and with copy to the designee who is identified to
Distributor in advance in writing.
1.6 All sales to Distributor are final. Any defective Product(s) must be
returned to the Manufacturer, with any such return being subject to the terms of
the warranty (Schedule 8 "Calmare(R)/Scrambler Warranty Coverage").
Specifically, CTTC shall indicate to the Distributor where defective Product(s)
along with required documentation are to be returned. The Distributor shall
submit and prosecute a claim for any Product(s) damaged in transit where the
Distributor is the shipper.
1.7 Without regard to whether the Patent(s) for Calmare(R)/Scrambler is
registered in a specific Territory, Distributor shall keep confidential and
secret any and all data and/or information, and intellectual property for the
Calmare(R)/Scrambler, including plans, specifications, operating parameters,
know-how, engineering, software, firmware, algorithm, hardware configurations
for assemblies, parts, components, casing and carts
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and manufacturing directions and configurations, and shall refrain from taking
any action or passing/sharing any information, whether electronic, written or
oral, whatsoever that could be used for cloning, reverse engineering or other
infringement of the intellectual property for the Calmare(R)/Scrambler and, more
specifically, the current Model MC-5A, and any future series or any related
assemblies, parts or components. Notwithstanding Section 2.2, any breach of this
Section 1.7, or infringement, after verification by CTTC, shall provide CTTC
with the right immediately to terminate this Agreement by sending to Distributor
a written notice of such a breach, by fax, courier or email, communicating the
immediate termination of this Agreement. In such termination for cause based on
infringement or misappropriation of intellectual property violating this
Agreement, CTTC shall collect from Distributor a penalty comprised of the
minimum of a fixed fee of $2,000,000 US Dollars as liquidated damages plus
additional actual damage awards to be determined by the appropriate court.
1.8 Distributor commits to (i) actively and continually market and promote
the Product(s) to appropriate potential customers and marketing channels; (ii)
use best efforts to promote the sale of the maximum quantity of Product(s); and
(iii) accurately advise potential customers of the selection, use and
functionality of the Product(s). Distributor shall keep CTTC informed as to
conditions that might affect the sale of the Product(s) in the marketplace.
1.9 Distributor shall refrain from taking actions that may tarnish the
reputation or image of CTTC or the Product(s). Distributor shall establish and
maintain an adequate marketing program and a sales force, and customer training
and technical service representatives, who are properly trained in all aspects
of the distributed Product and may routinely be reviewed by CTTC. CTTC shall
have the right to review and discuss with Distributor at reasonable times and
with reasonable frequency all aspects of the marketing and service program.
Distributor shall be solely responsible for establishing the terms of sale
(subject to any limitations set forth herein) including, without limitation, the
sale price of the Product(s), consummating the sale of any Product(s),
collecting the sale price, and for providing any post-sale service that may be
necessary with the exception of manufacturer warranty claims, which shall be
handled by the Manufacturer.
l.l0 To assist Distributor in marketing the Product(s), CTTC may provide
Distributor with such marketing materials as CTTC may deem appropriate. CTTC
shall also have the right to review/evaluate and to decide whether to authorize
any marketing materials mentioning CTTC or Calmare(R)/Scrambler that Distributor
might propose to disseminate. CTTC shall retain the sole discretion to change
marketing materials at any time and to provide such revised marketing materials
to Distributor for all future use. Distributor shall have obligation to use such
materials (so long as such marketing materials do not offend local law, custom
or business practice) and shall defray any cost for translation and printing
into local language(s) for distribution of the materials, or of substitute
materials proposed to and approved by CTTC to avoid offense under local law,
custom or business practice, within "Territory".
1.11 Distributor shall attend and participate, at its own cost for travel
and accommodation, with at least one representative, at any global Marketing
Event to which Distributor is invited by CTTC.
1.12 Distributor shall participate with own exhibit booth at least at 2
major National convention and meeting events, such as those of the Congress of
Oncology, Palliative Care, Anesthesia, and Neurology in Distributor's own
assigned Territory. Distributor
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shall provide an invitation, along with Hotel accommodation prepaid by
Distributor collocated with the convention or meeting, provided that CTTC shall
pay the travel cost of sending its own representative(s).
1.13 Distributor shall provide a written sales summary of actual and
forecasted sales monthly to CTTC according to the Reporting system that CTTC
shall issue. Each Monthly Report shall be provided to CTTC on or before the
fifteenth (15th) calendar day of the next month. Any further useful commercial
information requested by CTTC or delegates has to be provided by Distributor.
1.14 The authority granted to Distributor is to distribute those Product(s)
it has purchased from CTTC solely within the Territory. Moreover, Distributor
shall not sell Product(s) to purchasers outside the Territory or to purchasers
inside or outside the Territory that Distributor believes or has reason to
believe are primarily intended for use or distribution outside the Territory
without written permission from CTTC. Distributor shall not have, nor shall it
hold itself out as having, either express or implied authority to accept orders
for the Product(s) on behalf of CTTC or to make contracts in the name of CTTC or
any other Party.
1.15 Distributor acknowledges and agrees that Distributor is an independent
contractor under the laws and rules of the United States Internal Revenue
Service (as well as any foreign equivalent) and the laws and procedural holdings
of the State of Connecticut. Distributor is not an employee of CTTC or any
subsidiary of CTTC, and Distributor shall not represent itself to be, nor permit
itself to be represented as, anything other than a Distributor of the
Product(s). Distributor does not and shall not have any power to, nor shall it
represent that it has any power to, bind CTTC or create or assume any obligation
on behalf of CTTC.
1.16 Distributor shall comply, at all times, with all foreign, federal,
state and local laws and regulations applicable to it, including without
limitation, all applicable laws relating to the marketing, sale and distribution
of medical devices within the Territory. At NO time shall Distributor engage in
any high-pressure, morally questionable, unlawful or unethical sales techniques
(Schedule 14 "Ethical Code").
1.17 Distributor shall not make any representations or warranties with
respect to the Product(s) beyond the product warranties given by the
Manufacturer of the Product(s). In the event Distributor may require any
specific additional or extended warranty in its own Market, Distributor shall
advise CTTC of Distributor's perceived need and proposed solution that shall
simply verify to CTTC that the Distributor's modification is necessary and shall
not affect negatively CTTC activities on a global scale. If the change is needed
without major negative impact, CTTC shall grant the request at Distributor's own
cost and activity.
1.18 Distributor shall be required to strictly follow CTTC's authorized
training protocol for certification of medical personnel in the use and
application of the Scrambler Therapy program and MC-5A medical device, in
association with the strict compliance of the Calmare(R) User's Manual of the
device, both of which may be modified from time to time by CTTC. The protocol
(Schedule 10 " Calmare(R)/Scrambler Authorized Training") is absolutely
mandatory in its entirety and must be followed by Distributor as modified by
CTTC from time to time.
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1.19 Distributor shall be required to use only the Clinical Studies
officially published (please see Schedule 15 "Clinical Studies List/Plan") and
cleared by CTTC. Whilst further Clinical Studies to assess the effectiveness of
Calmare(R)/Scrambler are unnecessary, additional studies could be performed with
CTTC approval to determine the effectiveness of the Product(s) for other medical
conditions or for local Market requirements. In the event Distributor believes
additional clinical studies are necessary, Distributor shall seek guidance and
authorization from CTTC, and more specifically shall communicate requirement to
Delta Research & Development and Xxxxxxxxx Xxxxxxxx Xxxxxxx for their
evaluation. Xxxxxxxxx Xxxxxxx alone would expressly provide the final scientific
acceptance of the protocol and validation of any additional Study. Thereafter,
CTTC shall communicate to Distributor approval of any Clinical Study to be
performed locally along with payment requirements by the Principal Investigator
or Distributor. CTTC, in its sole discretion, may decide to share in the costs
of such Study if CTTC decides the Study may have strategic importance to CTTC.
In any event, CTTC shall retain all decision-making authority regarding payment
of the financial commitments and the continuous supervision and approval of such
Studies.
1.20 Distributor shall comply strictly with CTTC's mandated Chain of Custody
and Title Documentation Procedure, (Schedule 16 "Chain of Custody and Title
Documentation Procedure") to maintain detailed records of the identity of the
legal owner and any end-user and the physical location for each
Calmare(R)/Scrambler sold, temporarily placed for demonstration purposes,
leased, donated or otherwise permanently or temporarily removed from
Distributor's legal or beneficial ownership, custody or control. Distributor
shall maintain and provide CTTC on a monthly basis, or immediately at any other
time when requested by CTTC via email (or any other means), with all of
Distributor's chain of custody and title documentation. Distributor shall comply
with all applicable local privacy and other laws in assembling and maintaining
chain of custody and title documentation. The Parties acknowledge that the Chain
of Custody and Title Documentation Procedure (a) is essential because CTTC may
need to notify owners, lessees, donees and other end-users from time to time of
recalls or updates that could be important to the safety or effectiveness of
medical devices subject to this Agreement that include the Calmare(R)/Scrambler
units and related accessories in the interests of CTTC and, derivatively,
Distributor and its customers, and (b) may be modified by CTTC from time to time
as convenient or necessary.
1.21 Distributor shall comply strictly with CTTC's authorized Adverse Event
Procedure, (Schedule 17 "Adverse Event Procedure") to report whenever
Distributor receives notice or a claim from an owner, lessee, donee or other
end-user of a Calmare(R)/Scrambler unit or from any governmental entity or third
Party of a claim of injury in operation or ineffectiveness in operation or
noncompliance in any way with any national, stale, provincial or other local
government requirement or international standard, including, but not limited to,
any claim of violation or noncompliance with any directive of Food and Drug
Administration or any equivalent organization and any governing patent or CE
Xxxx, trademark or copyright governmental issuing authority or of any adverse
third Party contesting intellectual property rights in or to the
Calmare(R)/Scrambler unit or related accessories or intellectual property. The
Parties acknowledge that the Adverse Event Procedure (a) is essential because
CTTC may need to respond expeditiously to adverse governmental or third Party
notice or action for the protection of the rights and interests of CTTC and,
derivatively of Distributor and its customers; and (b) may be modified by CTTC
from time to time as convenient or necessary.
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1.22 Distributor shall comply strictly with CTTC's authorized Help Desk
Procedure, (Schedule 18 "Help Desk Procedure") to ensure prompt reporting to
CTTC of any technical or usage problem, concern or question related in any way
to the Calmare(R)/Scrambler units, any accessory or any associated
documentation, usage or training. The Parties acknowledge that the Help Desk
Procedure (a) is the optimal and most cost-effective method for Distributor and
its customers, including any owner, lessee, donee or other end-user of a
Calmare(R)/Scrambler unit, to present issues to and to obtain answers from, the
CTTC Help Desk in order to access and to contribute to and dynamically to update
CTTC's knowledge on the operation of the Calmare unit and related accessories;
and (b) may be modified by CTTC from time to time as convenient or necessary.
1.23 Distributor's rights under this Agreement shall terminate and CTTC
shall have no further obligations under this Agreement, beyond fulfillment of
the warranties on any Product(s), if Distributor shall be owned in whole or in
part by Life Episteme SARL or any affiliate, principal or member of LEG after
April 11, 2011; provided, however, that the triggering of this condition
subsequent shall not affect the obligation of Distributor in relation to CTTC
for any Products for which payment is due and owing to CTTC; provided further
that Distributor shall make payment to CTTC as agreed for any Product(s) for
which payment is due and owing to CTTC in accordance with agreed payment terms
even if this condition subsequent is triggered and this Agreement thereby
terminates in all other respects; and provided further that the triggering of
this condition subsequent shall eliminate all purchase, sale and payment
obligations between the parties on any order that has already been placed, but
not fully performed, as well as on any anticipated future order.
2.0 TERM OF AGREEMENT
2.1 Subject to the other provisions of this Agreement, the term of this
Agreement shall be for an initial period of 60 (sixty) months from the Effective
Date (the "Initial Term"): provided, however, that the term may be extended for
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additional periods of sixty (60) month periods (each a "Renewal Term" and,
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collectively with the Initial Term, the "Term") so long as (i) CTTC shall
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continue to have rights to the Product(s), which rights CTTC shall use all
commercially reasonable efforts to maintain, and (ii) Distributor (a) .shall
have honored the present Agreement in its entirely and specifically shall have
purchased from CTTC (and not returned) Product(s) equal to or in excess of the
applicable Quarterly Product Minimums, as set forth in (Schedule 19 "Multi
Annual Volume Budget") during each Quarter for the just ended Contract Year
(i.e., the Initial Term or Renewal Term, as applicable); (b) shall have made all
payments on a timely basis; and (c) shall have complied with all other material
terms and conditions of this Agreement. Once given, a continuation notice shall
become an irrevocable obligation of Distributor. Each of the Initial Term and
each Renewal Term may be referred to as a "Contract Year." Each Contract Year
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shall be divided into four (4) equal periods, with each such period referred to
as a "Contract Year Quarter." In turn, the Initial Term or any Renewal Term
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shall be divided into Contract Years. Notwithstanding the foregoing, Distributor
may prevent any auto-renewal of the Term by providing CTTC with written notice
of its intent to terminate this Agreement at least ninety (90) days prior to the
end of the then-current Term.
2.2 Either Distributor or CTTC may terminate this Agreement at any time if
the other Party shall materially breach its obligations hereunder; provided,
however, that the non-breaching Party shall give the breaching Party written
notice of such breach, and
CTT8K41908
the breaching Party shall have thirty (30) calendar days after receipt of such
notice to cure such breach. If such breach is cured to the reasonable
satisfaction of the non-breaching Party during such period, then this Agreement
shall continue in full force and effect. If such breach is not cured to the
satisfaction of the non-breaching Party during such period, then this Agreement
shall terminate effective upon the close of business on the last day of such
period.
2.3 In the event CTTC shall no longer have the right to sell the Product(s),
Distributor's right to sell such Product(s) shall immediately terminate, and
CTTC shall have no liability whatsoever to Distributor arising from such
termination unless CTTC is determined by binding arbitration or a court of
competent jurisdiction to have engaged in material breach that resulted in its
loss of its right to sell the Product(s). To the extent such termination does
not apply to all of the Product(s), this Agreement shall continue with respect
to the remaining Product(s) in accordance with its terms.
2.4 CTTC shall be liable for actual, direct compensatory damages in the
event of breach or wrongful termination by CTTC, but CTTC shall not be liable
for any incidental or consequential damages, compensation or indemnification of
any kind arising from the termination or expiration of this Agreement, or for
terminating with or without cause without a material breach by Distributor at a
time when CTTC continues to have rights to sell the Product(s), whether said
damages, compensation or indemnification are based on losses caused by previous
commitments of Distributor, loss of investments, loss of present or prospective
profits, loss of goodwill or clients, or any other loss arising from the
termination or expiration of this Agreement.
2.5 The terms and conditions of the following sections shall survive any
termination or expiration of this Agreement: Sections 1.7, 1.9, 1.15, 2.0, 3.0,
4.0, 5.0, 6.0, 7.0, 8.0 and 9.0, as well as any other provisions that may be
necessary to interpret the same.
3.0 COMMERCIAL OBLIGATIONS
3.1 Distributor shall be obligated to purchase from CTTC that number of
Product(s) during each Contract Year Quarter of each Contract Year as is set
forth in Schedule 19 "Multi Annual Volume Budget" for each such Contract Year
Quarter (the "Quarterly Product Minimums"). The Quarterly Product Minimums for
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each of the first four (4) Contract Year Quarters are set forth in Schedule 19
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hereto. The Quarterly Product Minimums for Contract Year 6 and beyond shall be
set by CTTC in good faith taking into account the number of sales and the
Quarterly Product Minimums (on both a quarterly and annual basis) for the prior
Contract Year and shall be provided to Distributor at least ninety (90) days
prior to the beginning of such new Contract Year
3.2 Distributor shall pay the price per unit established in Schedule 13
"Pricing. Distributor shall also pay in addition any import and/or customs duty
and shipping cost. Normal delivery under this Agreement shall be VIA OCEAN-GOING
SHIPPING CONTAINERS. If urgent Air shipping is needed, the Distributor must make
that request to CTTC and pay any additional shipping costs which shall be for
the account of Distributor.
3.3 Distributor shall be obligated AT THE SIGNATURE OF THIS AGREEMENT to
place an Order with CTTC for the number of units equivalent to the first
Contract
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Year Quarter stated in Schedule 19 "Multi Annual Volume Budget". Distributor
shall place an identical Order again with CTTC during each year of the Agreement
as stated for the first Calendar Year Quarter in Schedule 19 "Multi Annual
Volume Budget". ANY FAILURE BY DISTRIBUTOR TO PLACE THESE ORDERS WITH CTTC
ALLOWS CTTC TO TERMINATE IMMEDIATELY THIS DISTRIBUTION AGREEMENT WITHOUT PRIOR
NOTICE TO DISTRIBUTOR.
3.4 For acceptance, an Order must be sent on an official Distributor Order
form or Letter containing the same clauses and conditions stated in the
International standard CTTC form (Schedule 20 "CTTC International Order Form")
that is attached to this Agreement; each CTTC International Order Form, shall be
submitted properly stamped and signed by a representative who has full authority
to commit Distributor and shall be acknowledged by a representative who has full
authority to commit CTTC.
3.5 Distributor shall be required to pay in advance via International Wire
Transfer in the amount of 50% of the total cost in United States Dollars of any
Order to CTTC. The remaining 50% balance of the total cost in United States
Dollars shall be paid within 60 days of the end of the month in which the
invoice is dated. If any Product(s) arrive damaged, defective, or without the
proper legal documentation needed for Client acceptance, the cost of such
Product(s) shall be deductible from the total amount due and the payment for
replacement Product(s) terms for properly rejected Produces) shall be due within
60 days of the end of the month in which such Product(s) have been substituted;
provided, however, that Distributor shall be required to file, to prosecute and
to collect any claim for damage to Product(s) by the carrier in transit when the
Distributor is the shipper. Distributor may be eligible for deferral of payment
of 50% of the purchase price only so long as the Distributor shall remain in
strict compliance with these payment terms. If CTTC determines that the
creditworthiness of the Distributor or that the political or business climate
within the Territory places payment at risk, CTTC shall have the unilateral
right to engage in a "Credit Validation" according to objective parameters
commonly used in the Territory, such as "Basilea 3" for the Distributor and
International Country Rating by Standard & Poor's for the "Country risk" level,
or other generally recognized rating services. In the event that the
creditworthiness of Distributor is ascertained by objective standards to be
sub-par. then CTTC may unilaterally demand that the Distributor ensure payment
by a guaranteed irrevocable International Letter of Credit by an acceptable Bank
with payment of 50% of the amount by CTTC draw down at the time of acceptance of
the Order and 50% within 60 days of the end of the month in which the Order is
received by CTTC. The Distributor will at all times reserve the right to pay
100% of the amount of an Order at the time of that Order. CTTC shall have a
purchase money security interest in all units for which CTTC has not received
payment in full from Distributor. The Parties acknowledge that this purchase
money security interest shall apply neither to a bona fide purchaser for value
without notice nor to any Product(s) sold by Distributor to that bona fide
purchaser for value without notice prior to payment in full from Distributor to
CTTC. CTTC may take any action necessary or appropriate to protect its purchase
money security interest in any units.
3.6 Distributor shall pay interest to CTTC, on any amount unpaid when due,
in the amount determined as one percent (1%) above the EuRibor rate for 3-month
obligations on the payment due date.
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4.0 COMPENSATION
As between CTTC and Distributor, subject to CTTC's right to payment in full of
the purchase price by Distributor to CTTC, Distributor shall be entitled to
retain one hundred percent (100%) of all amounts received from the purchaser of
a Product. All travel, promotional, entertainment and other expenses and taxes
incurred by Distributor in its efforts to market and promote the Product(s)
shall be the sole obligation of Distributor, and Distributor shall not be
entitled to reimbursement of any kind from CTTC.
5.0 CONFIDENTIALITY; NON-DISPARAGEMENT
5.1 Confidentiality.
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a. As used herein, "Confidential Information'' means private, confidential,
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trade secret or other proprietary information (whether or not embodied or
contained in some tangible form) relating to any actual or anticipated business
of CTTC or its clients, including, without limitation, any information which, if
kept secret, would provide CTTC or its clients with an actual or potential
economic advantage over others in the relevant trade or industry, such as, but
not limited to: business data (including cost data), price lists, strategies and
compensation. Confidential Information shall not include information that: (i)
at the time of first disclosure by CTTC to Distributor was already in the
possession of Distributor by legal and proper means, as shown by written records
existing at such time; (ii) is independently made available to Distributor on a
non-confidential basis by an unrelated and independent third Party whose
disclosure does not constitute a breach of any duty of confidentiality owed to
CTTC or its clients; or (iii) is generally available to the public in a
readily-available document.
b. Except in an actual or potential business relationship with CTTC or its
clients, or with the prior written authorization of CTTC, Distributor shall not
directly or indirectly use, disclose, disseminate, publish or otherwise reveal
any Confidential Information for the benefit of any Party other than CTTC or its
clients. In the event that Distributor is required by legal process (court
order, subpoena, etc.) to disclose Confidential Information, Distributor shall
first (unless expressly prohibited by law) provide CTTC with notice and the
opportunity to take appropriate action to preserve the confidential nature of
the information; provided, that in the event CTTC elects not to seek an order
securing, or is unsuccessful, in whole or in part, in securing, the
confidentiality of the information to be disclosed, Distributor shall limit such
disclosure to the minimum amount of Confidential Information necessary to comply
with the applicable legal process as established by the written opinion of
Distributor's counsel.
c. Upon termination of Distributor's discussions with CTTC concerning a
potential business relationship or the termination of any actual business
relationship, in either case, for any reason, or upon CTTC's earlier request,
Distributor shall return to CTTC or destroy all Confidential Information and any
and all copies or reproductions thereof, and any documents or materials
containing Confidential Information, in any case, whether tangible or
intangible, in Distributor's possession or control.
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5.2 Non-Disparagement. Distributor acknowledges that any disparaging
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comments by Distributor or its principals, employees or agent against CTTC or
the Product(s) are likely to substantially harm the business reputation of, and
depreciate the value of, CTTC. As such, Distributor agrees to act in good faith
so as not to harm the business reputation of CTTC or the Product(s) in any way,
which includes Distributor's Agreement not to defame or publicly criticize the
services, business, integrity, veracity or reputation of the Product(s) or CTTC,
its officers, directors, managers, members, employees, affiliates or agents
thereof, in either a professional or personal manner. The provisions of this
Section shall survive any termination or expiration of this Agreement for a
period of five (5) years.
6.0 CONFLICT OF INTEREST
6.1 Distributor shall not sell or distribute products, directly or
indirectly, that are in competition with the Product(s) subject to this
Distribution Agreement without Distributor's prior written authorization
following full disclosure by Distributor to CTTC.
6.2 Distributor may sell or distribute other products, directly or
indirectly in competition with the Product(s) subject to this Distribution
Agreement, only upon prior written authorization by CTTC following by
Distributor's full disclosure to CTTC.
6.3 Distributor expressly represents and warrants that none of the
individuals, indicated by letter agreement between the parties, shall now or at
any time in the future have any interest in Distributor or any involvement
whatsoever in the performance of this Agreement
7.0 ASSIGNMENT OR SUBCONTRACTING
7.1 Distributor may not assign or transfer this Agreement, or any interest
therein or claim hereunder, or subcontract any rights hereunder, without the
prior written approval of CTTC. If CTTC consents to such assignment or transfer,
the terms and conditions of this Agreement shall be binding upon any assignee or
transferee and shall not relieve Distributor of its obligations hereunder.
7.2 Upon advance approval by CTTC, Distributor may contract with
Sub-Distributors who are marketing channel partners within the Territory.
Distributor shall be solely responsible for the compensation of any approved
Sub-Distributors, and Sub-Distributor shall sign an Agreement in form stated or
approved by CTTC subjecting the Sub-Distributor to the terms and conditions to
which Distributor is subject pursuant to this Agreement. Any Sub-Distributor
shall not be in privity of contract with CTTC, nor shall any Sub-Distributor be
a third-party beneficiary of this or any other Agreement between CTTC and
Distributor or any other Party. Distributor shall assure that the
Sub-Distributor shall comply, at all times, with all foreign, federal, state and
local laws and regulations applicable to it, including, without limitation, all
applicable laws relating to the marketing, sale and distribution of medical
devices within the Sub-Distributor's territory. It is responsibility of the
Distributor to monitor and to assure that each that each Sub-Distributor
complies with Schedule 14 "Ethical Code" and that at NO time does any
Sub-Distributor engage in any high-pressure, morally questionable, legally
improper or unethical sales technique.
CTT8K41912
8.0 INDEMNIFICATION; LIMITATION OF LIABILITY
8.1 Distributor shall defend, indemnify, reimburse and hold CTTC harmless
from and against any and all liabilities, losses, damages and costs, including
reasonable attorneys' fees (collectively, "Losses"), or resulting from or
-------
arising out of third Party claims based upon, (a) the grossly negligent,
intentionally wrongful or illegal acts or omissions of Distributor; or (b) any
actions of Distributor beyond its authority granted hereby, including the making
of any representation with respect to Product(s).
8.2 Except as provided under section 8.1 or with respect to breaches of the
confidentiality provisions or scope of distributor grant, in no event shall
either Party be liable under this Agreement or otherwise to the other for more
than the actual compensatory damages incurred by the Party making the claim, and
neither Party shall be liable for any incidental, indirect, punitive,
consequential or special damages arising out of or in connection with the
Agreement regardless of whether such claims are asserted in contract, tort,
warranty, strict liability, negligence, or otherwise, even if advised of the
possibilities of such damages. In no event shall the aggregate liability of CTTC
arising under or in connection with this Agreement (or any breach or violation
hereof) exceed the amount paid by Distributor to CTTC under this Agreement. Such
limitation is an essential and material provision of this Agreement and was a
condition upon which the terms and pricing were based.
9.0 MISCELLANEOUS
9.1 Amendment and Waiver. Any provision of this Agreement may be amended or
waived only with the written and signed consent of both Parties.
9.2 Severability. If any provision of this Agreement shall be held to be
illegal, invalid, or unenforceable, such provision shall be enforced to the
maximum extent permissible so as to effectuate the intent of the Parties, and
the validity, legality, and enforceability of the remaining provisions shall not
in any way be affected or impaired thereby.
9.3 Applicable Law. Parties to this Distribution Agreement shall be subject
to all applicable international conventions and laws, provided, however, in the
event of a conflict of laws, then laws of the State of Connecticut, U.S.A.,
shall be applied.
9.4 Arbitration. The Parties agree that any dispute between them shall be
brought before the American Arbitration Association in Washington, D.C. and that
only a court in the State of Connecticut, U.S.A. shall have jurisdiction over
any dispute and consequent arbitration.
9.5 Forum. The Parties agree that only a court in the State of Connecticut,
U.S.A. shall have jurisdiction over any dispute and consequent arbitration.
9.6 Notice. Any payment, notice, or other communication required or
permitted to be made to either Party hereunder shall be sufficiently made or
given (i) on the second business day after mailing if sent to such Party by
internationally recognized overnight courier, (ii) in the next business day
after receipt of confirmation of successful transmission if sent by facsimile,
and (iii) upon receipt if given by hand
CTT8K41913
delivery, in each case, at its address given below, or such other address as it
shall hereafter designate to the other Party in writing:
IN THE CASE OF COMPETITIVE TECHNOLOGIES, INC.:
---------------------------------------------
Xxxxxxx X. Xxxxxxx
Chief Executive Officer
Competitive Technologies, Inc.
0000 Xxxxx Xxxxxxx Xxxx, Xxxxx 000
Xxxxxxxxx, XX 00000, X.X.X.
x0 000.000.0000
WITH A COPY TO (WHICH SHALL NOT CONSTITUTE NOTICE):
--------------------------------------------------
Xxxxxxx Sale, Esq.
Sale & Xxxxx, P.C.
000 00,x Xxxxxx, X.X., 0,x Xxxxx
Xxxxxxxxxx, XX 00000
0 000.000.0000 (facsimile)
1 202.833.4170 (main)
0 000.000.0000 (private line)
IN THE CASE OF DISTRIBUTOR:
--------------------------
Xxxxxx Xxxxxxxxx
Life Episteme Italia S.r.l.
Xxx Xxx Xxxxxxx 00, 00000 Xxxx XX, Xxxxx
x00 (0)0 00000000
9.7 INTEGRATION. This Agreement expresses the full contract between the
Parties, and all other prior or contemporaneous oral or written representations
with regard to the subject matter hereof shall be of no effect
9.8 INTERPRETATION, HEADINGS, NUMBER AND GENDER. The Parties acknowledge and
agree that this Agreement has been freely negotiated and shall be deemed to have
been drafted by the Parties jointly. Accordingly, no court should construe any
provision for or against any Party as a result of such Party being involved in
the drafting of this Agreement. The headings of the several sections are
inserted for convenience of reference only, and are not intended to be part of
or to affect the meaning or interpretation of this Agreement. In this Agreement,
where the context so permits, the singular shall include the plural, and vice
versa, and references to a particular gender shall include the other genders.
The words '"include," "includes" and "including" are not limiting and shall be
interpreted as if followed by the phase "without limitation." Unless the context
indicates otherwise, the term "or" shall be deemed to include the term "and."
9.9 FORCE MAJEURE. No Party hereto shall be liable in damages or have the
right to cancel this Agreement for any delay or default in performing hereunder
if such delay or default is caused by conditions beyond its control, including
but not limited to acts of God, binding government restrictions, wars, or
insurrections.
9.10 SIGNATURES AND EXECUTION. This Agreement shall not be binding upon the
Parties until it has been duly executed by or on behalf of each Party, in which
event it shall be effective on the Effective Date. The Parties' pdf version, and
a print-out of that
CTT8K41914
pdf version, of this Agreement shall have the effect, and shall be fully binding
on the parties in the same fashion, as the document with original signatures.
9.11 Counterparts. This Agreement may be executed in three (3) or more
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument. Delivery of an executed
counterpart of this Agreement by facsimile shall be equally effective as
delivery of an original executed counterpart of this Agreement.
9.12 Authorized Signatories. The undersigned individuals each represent and
warrant that they have the authority to execute this Agreement on behalf of
their respective companies or in their individual capacities, as the case may
be.
9.13 No Third-Party Beneficiary. The Parties expressly acknowledge that no
Party other than CTTC and Distributor shall be a Party to or beneficiary of this
Agreement. The Parties expressly state their intention not to create, and in
fact do not create, any third-Party beneficiary by, to or under this Agreement.
9.14 English as Controlling Language; PDF Signatures. Both Parties represent
that they have carefully read this English language Agreement, which alone
represents the agreement of the Parties, that they understand this English
language Agreement and that they accept all terms and conditions stated in this
English language Agreement; and the Parties acknowledge that Parties' signed pdf
version, and a print-out of that signed pdf version, of this Agreement shall
have the same effect, and shall be fully binding on the parties in the same
fashion, as the document with original signatures.
[Signature page follows]
CTT8K41915
IN WITNESS WHEREOF, the Parties hereto have executed this Agreement as of the
dates shown below.
Competitive Technologies, Inc. Life Episteme Italia S.r.l.
By: \s\ Xxxxxxx X. Xxxxxxx By: \s\Xxxxxx Xxxxxxxxx
---------------------- -------------------
Name: Xxxxxxx X. Xxxxxxx Name: Xxxxxx Xxxxxxxxx
Title: Chief Executive Officer Title: President
Date: March 31st 2011 Date: March 31st 2011
--------------- ---------------
CTT8K41916
SCHEDULE 2
CALMARE(R)/SCRAMBLER AND OTHER ASSOCIATED USED NAMES
COMPETITIVE TECHNOLOGIES
17 March 2011
Subject: Declaration of Product Names
This document declares that all of the following names refer to medical device
for distribution and technology developed by Xxxxxxxxx Xxxxxxxx Xxxxxxx and
presented in documents by Competitive Technologies, Inc. all refer to
Calmare(R)/Scrambler:
Apparatus and Method for Quick Pain Suppression
Transcutaneous Electrical Nerve Stimulator for Pain Relief
Pain Stopper
Electrical Neuropathic Treatment
Scrambler
Scrambler Therapy
Scrambler Technology
Scrambler MC-5A
Calmare(R) Pain Therapy
Calmare(R) MC-5A
Declared By:
\S\ XXXX X. XXXXX
-----------------
NAME: XXXX X XXXXX
TITLE: EXECUTIVE VICE PRESIDENT
0000 Xxxxx Xxxxxxx Xxxx Xxxxx 000 Xxxxxxxxx, XX 00000 Voice: 000.000.0000 Fax:
203.368.5399
Website: xxx.xxxxxxxxxxxxxxx.xxx
CTT8K41917
SCHEDULE 5
CALMARE(R)/SCRAMBLER FDA CLEARANCE
510(K) SUMMARY FOR THE COMPETITIVE TECHNOLOGIES, INC. SCRAMBLER THERAPY MC-5A
TENS DEVICE (PER 21 CFR 807.92)
1. SuBMITTER/510(k) Holder
Competitive Technologies, Inc.
000 Xxxxxxxx Xxxxx
Xxxxxxxxx, XX 00000
Contact Person: Xxxx Xxxxx
Telephone: 000-000-0000
Date Prepared: May 1, 2008
2. Device Name
Proprietary Name: Scrambler Therapy MC-5A TENS Device
Common/Usual Name: Electrical Nerve Stimulator
Classification Names: Transcutaneous Electrical Nerve Stimulator
3. Predicate Devices
- Xxx XX-000, X000000
- Xxxxx Xxxx 6, K0620O3
4. Device Description
The Scrambler Therapy MC-5A TENS Device is a multi-channel TENS device which
allows simultaneous treatment of a number of pain sites. Stimulation impulses
are generated and controlled according to a stored program to provide pain
relief.
5. Intended Use
The Scrambler Therapy MC-5A TENS Device is indicated for:
- Symptomatic relief of chronic, intractable pain, post-surgical and
post-traumatic acute pain
CTT8K41918
- Symptomatic relief of acute pain
- Symptomatic relief of post-operative pain
6. Technological Characteristics and Substantial Equivalence
Competitive Technologies, Inc. claims substantial equivalence of the Scrambler
Therapy MC-5 A TENS Device to the predicate devices based on the intended use,
fundamental technology, and operation characteristics. A side-by-side comparison
of the Scrambler Therapy MC-5A TENS Device and the cited predicate devices is
included in the 510(k).
7. Performance Testing
Testing of the Scrambler Therapy MC-5A TENS Device demonstrates that the device
meets design and performance specifications.
CTT8K41919
Food and Drug Administration
0000 Xxxxxxxxx Xxxxxxxxx
Xxxxxxxxx XX 00000
Competitive Technologies, Inc.
c/o Medical Device Consultants, Inc.
Ms. Xxxx XxXxxxxx-Xxxxxxxxx, RAC
Senior Regulatory Affairs Specialist
00 Xxxxx Xxxxxx
Xxxxx Xxxxxxxxx, Xxxxxxxxxxxxx 00000
Re: K081255
Trade/Device Name: Competitive Technologies, Inc. Scrambler Therapy MC-5A
TENS Device
Regulation Number: 21 CFR 882.5890
Regulation Name: Transcutaneous, electrical nerve stimulator for pain relief
Regulatory Class: II
Product Code: GZJ
Dated: February 6, 2009
Received: February 9, 2009
Dear Xx. XxXxxxxx-Xxxxxxxxx:
We have reviewed your Section 510(k) premarket notification of intent to market
the device referenced above and have determined the device is substantially
equivalent (for the indications for use stated in the enclosure) to legally
marketed predicate devices marketed in interstate commerce prior to May 28,
1976, the enactment date of the Medical Device Amendments, or to devices that
have been reclassified in accordance with the provisions of the Federal Food,
Drug, and Cosmetic Act (Act) that do not require approval of a premarket
approval application (PMA). You may, therefore, market the device, subject to
the general controls provisions of the Act The general controls provisions of
the Act include requirements for annual registration, listing of devices, good
manufacturing practice, labeling, and prohibitions against misbranding and
adulteration
If your device is classified (see above) into either class II (Special Controls)
or class III (PMA), it may be subject to such additional controls. Existing
major regulations affecting your device can be found in the Code of Federal
Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further
announcements concerning your device in the Federal Register.
----------------
Please be advised that FDA's issuance of a substantial equivalence determination
does not mean that FDA has made a determination that your device complies with
other requirement of the Act or any Federal statutes and regulations
administered by other Federal agencies. You must comply with all the Act's
requirements, including, but not limited to: registration and listing (21 CFR
Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements
as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if
applicable, the electronic product radiation control provisions (Sections
531-542 of the Act); 21 CFR 1000-1050.
CTT8K41920
Page 2 - Ms. Xxxx XxXxxxxx-Xxxxxxxxx, RAC
This letter will allow you to begin marketing your device as described in your
Section 510(k) premarket notification. The FDA finding of substantial
equivalence of your device lo a legally marketed predicate device results in a
classification for your device and thus, permits your device to proceed lo the
market.
If you desire specific advice for your device on our labeling regulation (21 CFR
Part 801), please contact the Center for Devices and Radiological Health's
(CDRH's) Office of Compliance at (000) 000-0000. Also, please note the
regulation entitled, "Misbranding by reference to premarket notification" (21
CFR Part 807.97). For questions regarding postmarket surveillance, please
contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of
Postmarket Surveillance at (000) 000-0000. For questions regarding the reporting
of device adverse events (Medical Device Reporting (MDR)), please contact the
Division of Surveillance Systems at (000) 000-0000. You may obtain other general
information on your responsibilities under the Act from the Division of Small
Manufacturers, International and Consumer Assistance at toll-free number (800)
638-2041 or (000) 000-0000 or the Internet address
xxxx://xxx.xxx.xxx/xxxx/xxxxxxxx/xxxxxxx/xxxxx.xxxx.
Sincerely yours,
Xxxx X. Xxxxxxxxx
Director
Division of General, Restorative and Neurological Devices
Office of Device Evaluation
Center for Devices and Radiological Health
CTT8K41921
INDICATIONS FOR USE
510(k) Number (if known): KQ81255
-------
Device Name: Competitive Technologies, Inc Scrambler Therapy MC-5A TENS Device.
------------------------------------------------------------------
Indications for Use:
The Scrambler Therapy MC-5A TENS Device is indicated for:
- Symptomatic relief of chronic, intractable pain, post surgical and
post-traumatic acute pain
- Symptomatic relief of acute pain
- Symptomatic relief of post-operative pain
Prescription Use X AND/OR Over-The-Counter Use
- --
(Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASEDONOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
----------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
CTT8K41922
SCHEDULE 9
CALMARE(R)/SCRAMBLER TECHNICAL ASSISTANCE
1. THE DISTRIBUTOR IS NOT AUTHORIZED TO PERFORM "ANY" INTERNAL SERVICING OF
THE CALMARE(R) MEDICAL DEVICE, SPECIFICALLY, MODEL MC-5A AND FUTURE CALMARE
DEVICES, UNLESS TRAINED, CERTIFIED AND AUTHORIZED BY COMPETITIVE TECHNOLOGIES,
INC.
2. ALL INTERNAL SERVICING WILL BE PERFORMED EXCLUSIVELY BY THE MANUFACTURER.
3. ALL DEVICES REQUIRING WARRANTY SERVICE MIL BE RETURNED TO THE
MANUFACTURER AS DESCRIBED IN THE WARRANTY DOCUMENT.
4. IN ALL CASES THE SENDER PAYS FOR SHIPMENT OF THE DEVICE TO THE
MANUFACTURER REQUIRING REPAIRS.
5. IF DEVICE IS DETERMINED TO BE DEFECTIVE DURING THE WARRANTY PERIOD THEN
DISTRIBUTOR WILL REPLACE DEFECTIVE DEVICE WITH NEW DEVICE FROM ITS OWN
INVENTORY, RETURN THE DEFECTIVE DEVICE TO THE MANUFACTURER AND UPON RECEIPT OF
THE DEFECTIVE DEVICE THE MANUFACTURER WILL SEND A NEW DEVICE TO RE-FILL THE
DISTRIBUTOR'S INVENTORY.
6. IF DISTRIBUTOR HAS NO DEVICES AVAILABLE IN INVENTORY THEN DISTRIBUTOR
WILL NOTIFY COMPETITIVE TECHNOLOGIES, INC. THE DISTRIBUTOR WILL SIMULTANEOUSLY
RETURN DEFECTIVE DEVICE TO CTTC AND CTTC WILL SEND A LOANER REPLACEMENT DEVICE
UNTIL THE DEFECTIVE DEVICE IS REPAIRED BY THE MANUFACTURER AND RETURNED.
7. THE MANUFACTURER WILL MAKE A BEST EFFORT TO REPAIR AND PREPARE THE
REPAIRED DEVICE FOR RETURN TO THE DISTRIBUTOR WITHIN FOURTEEN (14) DAYS OF
RECEIPT OF THE DEFECTIVE DEVICE.
8. IN THE FUTURE THIS PROCESS MAY BE MODIFIED WITH NINETY (90) DAYS NOTICE.
9. UPON EXPIRATION OF THE WARRANTY CTTC OFFERS THE DISTRIBUTOR THE OPTION OF
ADDITIONAL TECHNICAL ASSISTANCE AND REPAIRS FOR $[Confidential Information
Omitted] USD PER YEAR PER SOLD DEVICE. THIS IS PAYABLE AT THE BEGINNING OF EACH
YEAR AFTER THE WARRANTY EXPIRES.
Pursuant to Rule 24b-2 of the Exchange Act, confidential information on this
pagehas been omitted and marked as "[Confidential Information Omitted]", and has
been filed separately with the Securities and Exchange Commission pursuant to a
Confidential Treatment Application filed with the Commission.
CTT8K41923
SCHEDULE 10
CALMARE(R)/SCRAMBLER AUTHORIZED TRAINING
Distributor shall be required to strictly follow CTTC's authorized training
protocol for certification of medical personnel in the use and application of
the Scrambler Therapy program and MC-5A medical device, in association with the
strict compliance of the Calmare(R) User's Manual of the device. The full
content of this protocol is absolutely mandatory to be followed and may be
modified by CTTC from time to time.
The standard authorized training protocol will consist of 3-days of Calmare(R)
medical device training in the hands-on use with a diverse group of patients
diagnosed with chronic neuropathic pain and/or cancer pain, operation, efficacy
and safety of the MC-5A, or equivalent Calmare(R) device. The training will be
conducted by either Xxxxxxxxx Xxxxxxxx Xxxxxxx or a credentialed Calmare(R)
Medical Training Specialist. The distributor will be required to have an
appropriate level medical professional (physician and/or specialized registered
nurse) trained and certified. For training in "Advanced" techniques the medical
professionals will be required to attend training sessions in Rome, Italy. All
end-user physicians and specialized registered nurses will be required to
participate in a 3-day Calmare(R) training program.
At the completion of the 3-day Calmare(R) training the participants will be
required to demonstrate their comprehensive knowledge of Objectives and Goals.
End-User medical professionals will be required to continue their training and
experience with the Calmare(R) MC-5A by scheduling and completing treatment of a
minimum of three (3) patients per week (monoradicular and pluriradicular chronic
pain and/or cancer pain) over the course of thirty (30) business days as per the
Calmare(R) Treatment Protocol. CTTC will provide the list of Objectives and
Goals, the Calmare(R) Tutorial & Study Guide, Calmare(R) Treatment Protocol and
the User's Manual for the MC-5A, or equivalent Calmare(R) device. Upon
successful completion the participant will be awarded a Calmare(R) Scrambler
MC-5A User Certificate.
CTT8K41924
SCHEDULE 12
COUNTRY/ COUNTRIES IN ASSIGNED TERRITORY
ITALY
MALTA
CTT8K41925
SCHEDULE 13
PRICING
NR. OF UNITS PURCHASED IN EACH SINGLE ORDER
MC-5A UNITS: 1-2 [CONFIDENTIAL INFORMATION OMITTED]
MC-5A UNITS: 3-4 [CONFIDENTIAL INFORMATION OMITTED]
MC-5A UNITS: 5-7 [CONFIDENTIAL INFORMATION OMITTED]
MC-5A UNITS: 8-9 [CONFIDENTIAL INFORMATION OMITTED]
MC-5A UNITS: 10-20 [CONFIDENTIAL INFORMATION OMITTED]
MC-5A UNITS: + THAN 20 [CONFIDENTIAL INFORMATION OMITTED]
RECOMMENDED PRICE LIST FOR END USER IN US DOLLARS: $ [CONFIDENTIAL INFORMATION
OMITTED]
RECOMMENDED PRICE LIST FOR END USER IN EU EUROS: [CONFIDENTIAL INFORMATION
OMITTED]
NOTE: INTEGRALLY PART OF THE DISTRIBUTION AGREEMENT
---------------------------------------------------
1) FOR LIFE EPISTEME ITALIA DISTRIBUTOR PRICE IS ALWAYS US$[CONFIDENTIAL
---------------------------------------------------------------------
INFORMATION OMITTED]
--------------------
2) LIFE EPISTEME ITALIA FOR ANY 50 MC-5A DEVICES REGULARLY PURCHASED AND
---------------------------------------------------------------------
PAID, WILL RECEIVE FREE OF CHARGE (WITH ONLY DELIVERY CHARGES AND CUSTOMS DUTY
------------------------------------------------------------------------------
TO BE PAID LOCALLY) AT 0 (ZERO) US$ 1 ADDITIONAL MC-5A UNIT TO BE USED FOR FREE
-------------------------------------------------------------------------------
DEMO LOAN AND/OR AS BACKUP TO TEMPORARLY REPLACE ANY DEFECTIVE DEVICE ; ANY FREE
--------------------------------------------------------------------------------
OF CHARGE DEVICE WILL NOT BE ELIGIBLE FOR SALES
-----------------------------------------------
Pursuant to Rule 24b-2 of the Exchange Act, confidential information on this
pagehas been omitted and marked as "[Confidential Information Omitted]", and has
been filed separately with the Securities and Exchange Commission pursuant to a
Confidential Treatment Application filed with the Commission.
CTT8K41926
SCHEDULE 14
Competitive Technologies, Inc. Corporate Code of Conduct
Dear Colleague:
The financial success and value to society of Competitive Technologies, Inc.
(the "Company" or "CTTC"), as well as the respect it earns, depends not only on
the Company's financial performance, but also on the principles under which the
directors, officers and employees of the Company conduct its business. Pride in
our Company must be based both on what we accomplish and how we accomplish it.
CTTC's Corporate Code of Conduct (the "Code") reflects the philosophy that our
integrity and the manner in which we do business are essential to our success.
The Code is designed to give a broad and clear understanding of the conduct that
is expected of all of our employees, officers and directors, and goes beyond the
letter of the law. Where possible, specific guidance is provided; however, there
will almost certainly be situations where specific guidance is not provided by
the Code. An equally important source of guidance therefore must be each
individual's good judgment, sensitivity to what is right, and strong desire to
do nothing that might bring discredit upon the individual or the Company.
What you read in the Code probably will not surprise you, because the overriding
theme of the Code can be summed up as follows: representatives of CTTC must at
all times, and in all matters, act with integrity and honesty.
\s\ Xxxxxxx X. Xxxxxxx
Xxxxxxx X. Xxxxxxx
Chief Executive Officer
CTT8K41927
Schedule 15
Calmare(R) Scrambler Published Studies
1. XXXXX XX, XXXXX XX, XXXXXX XX, XXXXXX P, XXXXXXXXXXXX V. PILOT TRIAL OF A
PATIENT-SPECIFIC CUTANEOUS ELECTROSTIMULATION DEVICE (MC5-A CALMARE(R)) FOR
CHEMOTHERAPY-INDUCED PERIPHERAL NEUROPATHY. J PAIN SYMPTOM MANAGEMENT 2010;
40(6): 883-891.
2. MARINEO G, UNTREATABLE PAIN RESULTING FROM ABDOMINAL CANCER: NEW HOPE
FROM BIOPHYSICS? J PANCREAS 2003; 4:1-10.
3. XXXXX A, XXXXXX XX, MARINEO G. SCRAMBLER THERAPY IN NEUROPATHIC PAIN.
PATHOS 2007; 14: 99-105.
4. XXXXXX XX, MARINEO G, XXXXX A. SCRAMBLER THERAPY. XXXXXXX ANESTESIOLOGICA
2005; 71:479-482.
5. RICCI M, PIROTTI S, SCARPI E, XXXXXX M, MALTONI M, SANBONI E, AMADORI D.
MANAGING CHRONIC PAIN: RESULTS FROM AN OPEN-LABEL STUDY USING MC5-A CALMARE(R)
DEVICE. SUPPORT CARE CANCER 2011; PUBLISHED ONLINE 11 MARCH 2011.
6. MARINEO G, XXXXXXXX S, XXXXXX XX, XXXXXXX F. ARTIFICIAL NEURONS IN
ONCOLOGICAL PAIN: THE POTENTIAL OF SCRAMBLER THERAPY TO MODIFY A BIOLOGICAL
INFORMATION. INTERNATIONAL CONGRESS SERIES 2003; 1255: 381-388.
7. MARINEO G, IORNO V, GANDINI C, XXXXXXXX V, XXXXX XX. SCRAMBLER THERAPY
RELIEVES CHRONIC NEUROPATHIC PAIN MORE EFFECTIVELY THAN GUIDELINE BASED DRUG
MANAGEMENT. 2011; SUBMITTED.
CTT8K41928
SCHEDULE 15
Calmare(R) Scrambler Ongoing Clinical Studies
ELECTRICAL STIMULATION PAIN THERAPY IN TREATING CHRONIC PAIN AND NUMBNESS CAUSED
BY CHEMOTHERAPY IN PATIENTS WITH CANCER
This study is currently recruiting participants.
Verified by Virginia Commonwealth University, September 2010
First Received: September 3, 2010 Last Updated: September 10, 2010
SPONSOR: Virginia Commonwealth University
XXXXXXXXXXXXXX.XXX IDENTIFIER: NCT01196442
> Purpose
RATIONALE: Electrical stimulation pain therapy may help relieve chronic pain and
numbness caused by chemotherapy. PURPOSE: This pilot trial studies electrical
stimulation pain therapy in treating chronic pain and numbness caused by
chemotherapy in patients with cancer.
Official Title: An Expanded Trial of MC5-A Calmare Therapy
in the Treatment of Cancer Pain Syndromes
and Chronic Chemotherapy-Induced Peripheral
Neuropathy Including Pain and Numbness
Estimated Enrollment: 22
Study Start Date: September 2010
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date
for primary outcome measure)
Detailed Description:
OBJECTIVES:
I. To evaluate the effect of MC5-A on pain symptoms both immediately and
overtime.
II. To evaluate the effect of Calmare therapy on other non-pain symptoms.
III. To evaluate the effect of MC5-A on daily opioid and other pain medication
use.
OUTLINE: Patients undergo electric stimulation pain therapy comprising MC5-A
Calmare therapy over 30 minutes once daily for 10 days. After completion of
study treatment, patients are followed up for 3 months.
CTT8K41929
SCHEDULE 15
Calmare(R) Scrambler Ongoing Clinical Studies
MC5-A SCRAMBLER THERAPY IN REDUCING PERIPHERAL NEUROPATHY CAUSED BY CHEMOTHERAPY
This study is currently recruiting participants.
Verified by Mayo Clinic, February 2011
First Received: February 1, 2011 Last Updated: February 3, 2011
History of Changes
------------------
SPONSOR: Mayo Clinic
COLLABORATOR: National Cancer Institute (NCI)
INFORMATION PROVIDED BY: Mayo Clinic
XXXXXXXXXXXXXX.XXX IDENTIFIER: NCT01290224
> PURPOSE
RATIONALE: SCRAMBLER THERAPY may help relieve pain from PERIPHERAL NEUROPATHY
CAUSED BY CHEMOTHERAPY.
PURPOSE: This phase II trial is studying how well MC5-A SCRAMBLER THERAPY works
in REDUCING PERIPHERAL NEUROPATHY CAUSED BY CHEMOTHERAPY
Official Title: SCRAMBLER THERAPY for the TREATMENT of CHEMOTHERAPY Induced
PERIPHERAL NEUROPATHY: An Evaluation of a Sham PROCEDURE and Phase II Trial
DETAILED DESCRIPTION: PRIMARY OBJECTIVES:
I. To explore the feasibility of studying scrambler therapy versus a sham
procedure for the alleviation of lower extremity chemotherapy induced peripheral
neuropathy (CIPN).
SECONDARY OBJECTIVES:
I, To obtain prospective pilot experience with recommended scrambler therapy,
with regards to treatment efficacy to determine effect size estimates, patient
related outcome measurement tools that we use in this trial, tolerability, and
analgesic use.
OUTLINE. Patients undergo a sham procedure on the back or scrambler therapy on
both lower extremities for up to 30 minutes with the Calmare MC5-A device and
cutaneous electrode patches applied above and below the area of pain on days 1
and 2. Patients continue scrambler therapy for 10 days in the absence of
unacceptable toxicity.
CTT8K41930
SCHEDULE 15
Calmare(R) Scrambler Ongoing Clinical Studies
MC-5A FOR CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY
This study is not yet open for participant recruitment.
Verified by University of Wisconsin, Madison, December 2010
First Received: December 9, 2010 Last Updated: December 15, 2010 History of
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Changes
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SPONSOR: University of Wisconsin, Madison
INFORMATION PROVIDED BY: University of Wisconsin, Madison
XXXXXXXXXXXXXX.XXX IDENTIFIER: NCT01261780
> PURPOSE
Painful chemotherapy induced peripheral neuropathy (CIPN) is a common
complication of cancer THERAPY with few TREATMENT options. CIPN is a complex
side effect that varies between individuals and can be difficult to describe,
difficult to treat and can significantly effect quality of life for patients.
The purpose of this study is to determine if patients with painful CIPN will
have a decrease in pain scores after TREATMENT with the MC-5A device.
Official Title: TREATMENT of Painful Chemotherapy -Induced Peripheral Neuropathy
With the MC-SA Pain THERAPY Medical Device, a Randomized, Double-Blind,
Sham-Controlled Clinical Trial
Primary Outcome Measures:
- Change in Visual Analog Scale pre/post treatment [Time Frame: baseline,
before/after each treatment, and 3 months after treatment ] [Designated as
safety issue: No]
Secondary Outcome Measures:
- Adverse events [Time Frame: Daily with each treatment and at end of 3
month follow up period] [Designated AS safety issue: Yes] adverse events
according to CTCAE
CTT8K41931
SCHEDULE 16
CHAIN OF CUSTODY AND TITLE DOCUMENTATION PROCEDURE
The present schedule intends to be a mission description, and not the factual
Procedure, for the purpose of this Distribution Agreement of the Chain of
Custody and Title Documentation Procedure. Distributor shall comply strictly
with CTTC's factual Chain of Custody and Title Documentation Procedure, in any
present or future release, to maintain detailed records of the identity of the
legal owner and any end-user and the physical location for each
Calmare(R)/Scrambler sold, temporarily placed for demonstration purposes,
leased, donated or otherwise permanently or temporarily removed from
Distributor's legal or beneficial ownership, custody or control. Distributor
shall maintain and provide CTTC on a monthly basis, or immediately at any other
time when requested by CTTC via email (or any other means), with all of
Distributor's chain of custody and title documentation. Distributor shall comply
with all applicable local privacy and other laws in assembling and maintaining
chain of custody and title documentation. The parties acknowledge that the Chain
of Custody and Title Documentation Procedure (a) is essential because CTTC may
need to notify owners, lessees, donees and other end-users from time to time of
recalls or updates that could be important to the safety or effectiveness of
medical devices subject to this Agreement that include the Calmare(R)/Scrambler
units and related accessories in the interests of CTTC and, derivatively,
Distributor and its customers, and (b) may be modified by CTTC from time to time
as convenient or necessary.
CTT8K41932
SCHEDULE 17
Adverse Event Procedure
The present schedule intends to be a mission description, and not the factual
Procedure, for the purpose of this Distribution Agreement of the Adverse Event
Procedure. Distributor shall comply strictly with CTTC's factual Adverse Event
Procedure, in any present or future release, to report whenever Distributor
receives notice or a claim from an owner, lessee, donee or other end-user of a
Calmare(R)/Scrambler unit or from any governmental entity or third party of a
claim of injury in operation or ineffectiveness in operation or noncompliance in
any way with any national, state, provincial or other local government
requirement or international standard, including, but not limited to, any claim
of violation or noncompliance with any directive of Food and Drug Administration
or any equivalent organization and any governing patent or CE Xxxx, trademark or
copyright governmental issuing authority or of any adverse third party
contesting intellectual property rights in or to the Calmare(R)/Scrambler unit
or related accessories or intellectual property. The parties acknowledge that
the Adverse Event Procedure (a) is essential because CTTC may need to respond
expeditiously lo adverse governmental or third party notice or action for the
protection of the rights and interests of CTTC and, derivatively of Distributor
and its customers; and (b) may be modified by CTTC from time to lime as
convenient or necessary.
CTT8K41933
SCHEDULE 18
Help Desk Procedure
The present schedule intends to be a mission description, and not the factual
Procedure, for the purpose of this Distribution Agreement of the Help Desk
Procedure. Distributor shall comply strictly with CTTC's factual Help Desk
Procedure, in any present or future release, to ensure prompt reporting lo CTTC
of any technical or usage problem, concern or question related in any way to the
Calmare(R)/Scrambler units, any accessory or any associated documentation, usage
or training. The parties acknowledge that the Help Desk Procedure (a) is the
optimal and most cost-effective method for Distributor and its customers,
including any owner, lessee, donee or other end-user of a Calmare(R)/Scrambler
unit, lo present issues to and to obtain answers from, the CTTC Help Desk in
order to access and to contribute to and dynamically to update CTTC's knowledge
on the operation of the Calmare unit and related accessories; and (b) may be
modified by CTTC from time to time as convenient or necessary.
CTT8K41934
SCHEDULE 19
MULTI ANNUAL VOLUME BUDGET
MINIMUM
CONTRACT PERIOD BUDGET AGREED Possible GAP % Possible GAP Nr.
ALLOWED
Product: MC-5A Units Nr. of Units to Buy shortfall vs. BDG shortfall
vs. BDG Nr. of Units to Buy
FY 2011 1st Quarter Jan-Mar [Confidential Information Omitted]
FY 2011 2nd Quarter Apr-Jun [Confidential Information Omitted]
FY 2011 3rd Quarter Jul-Sept [Confidential Information Omitted]
FY 2011 4th Quarter Oct-Dec [Confidential Information Omitted]
FY 2011 TOTAL [Confidential Information Omitted]
FY 2012 1st Quarter Jan-Mar [Confidential Information Omitted]
FY 2012 2nd Quarter Apr-Jun [Confidential Information Omitted]
FY 2012 3rd Quarter Jul-Sept [Confidential Information Omitted]
FY 2012 4th Quarter Oct-Dec [Confidential Information Omitted]
FY 2012 TOTAL [Confidential Information Omitted]
FY 2013 1st Quarter Jan-Mar [Confidential Information Omitted]
FY 2013 2nd Quarter Apr-Jun [Confidential Information Omitted]
FY 2013 3rd Quarter Jul-Sept [Confidential Information Omitted]
FY 2013 4th Quarter Oct-Dec [Confidential Information Omitted]
FY 2013 TOTAL [Confidential Information Omitted]
FY 2014 1st Quarter Jan-Mar [Confidential Information Omitted]
FY 2014 2nd Quarter Apr-Jun [Confidential Information Omitted]
FY 2014 3rd Quarter Jul-Sept [Confidential Information Omitted]
FY 2014 4th Quarter Oct-Dec [Confidential Information Omitted]
FY 2014 TOTAL [Confidential Information Omitted]
FY 2015 1st Quarter Jan-Mar [Confidential Information Omitted]
FY 2015 2nd Quarter Apr-Jun [Confidential Information Omitted]
FY 2015 3rd Quarter Jul-Sept [Confidential Information Omitted]
FY 2015 4th Quarter Oct-Dec [Confidential Information Omitted]
FY 2015 TOTAL [Confidential Information Omitted]
CONTRACT GRANDTOTAL [Confidential Information Omitted]
Pursuant to Rule 24b-2 of the Exchange Act, confidential information on this
pagehas been omitted and marked as "[Confidential Information Omitted]", and has
been filed separately with the Securities and Exchange Commission pursuant to a
Confidential Treatment Application filed with the Commission.
CTT8K41935
PRIVATE ADDENDUM LETTER
-----------------------
INTEGRATING DISTRIBUTION AGREEMENT
----------------------------------
This PRIVATE LETTER is considered an INTEGRAL ADDENDUM to the Sub-Paragraph 6.3
of the DISTRIBUTION AGREEMENT, effective as of March 31st, 2011, entered into by
and between Competitive Technologies, Inc. ("CTTC") a Delaware corporation
-------
having a place of business at:
Competitive Technologies, Inc.
0000 Xxxxx Xxxxxxx Xxxx, Xxxxx 000
Xxxxxxxxx, XX 00000, X.X.X.
And Life Episteme Italia S.r.l. ("DISTRIBUTOR"), an Italian Company with its
-----------
legal headquarters at:
Xxx Xxx Xxxxxxx X.00, 00000 Xxxx, Xxxxxx
AGREEING THAT
Distributor expressly represents and warrants that NONE of the individuals below
mentioned will have, directly or indirectly now or at any time in the future any
cooperation or interest in the Distributor or any involvement whatsoever in the
performance of this Agreement; individuals are:
- Vincenzo De Bustis
- Xxxxxx Xxxxx
- Xxxxxxxx Xxxxxxxx
- Xxxxx Xxxx
- Xxxx X. Nano
- Xxxxxxxx Xxxxxxx
Also the Parties acknowledge that Xxxxxxx Xxxxxxxxx, formerly employed by LEG
and LEI, is employed by CTTC and that Xx. Xxxxxxxxx is excluded from the scope
of this representation and warranty, and that Xx. Xxxxxxxxx'x performance shall
not constitute any conflict of interest.
May 1st, 0000
/x/ Xxxxxx Xxxxxxxxx /s/ Xxxxxxx X. Xxxxxxx
Xxxxxx Xxxxxxxxx Xxxxxxx X. Xxxxxxx
Presidente Chief Executive Officer
Life Episteme Italia S.r.l. Competitive Technologies, Inc.
CTT8K41936
